Chronic hepatitis B
Conditions
Interventions
HBeAg-positive pregnant women with chronic hepatitis B group:None
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.20-40 years old; 2.HBsAg positive for >=6 months; 3.Check hepatitis B viral load before 24 weeks of pregnancy to ensure it is below 2×10^5 IU/ml; 4.Did not take antiviral drugs within six months before pregnancy and before 24 weeks of gestation;
Exclusion criteria
Exclusion criteria: 1.Used anti-hepatitis B virus medications (such as entecavir, tenofovir, tenofovir alafenamide, adefovir dipivoxil, telbivudine, etc.) within six months before pregnancy; 2.Accompanied by hepatitis A, C, or E virus infection, other hepatotropic virus infections, or AIDS; 3.Accompanied by cirrhosis, liver cancer, or other chronic liver diseases (such as alcoholic liver disease, autoimmune liver disease, G6PD deficiency, etc.); 4.Those with major organ diseases involving the heart (e.g., coronary heart disease, myocardial infarction, heart failure), lungs (e.g., lung cancer, COPD, tuberculosis), kidneys (e.g., renal failure, elevated creatinine, nephritis, nephrotic syndrome), etc. 5.Accompanied by chronic diseases such as autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome), hypertension, diabetes, and thyroid disorders; 6.Those with a history of pregnancy complications (such as gestational hypertension, gestational diabetes, preeclampsia, etc.); 7.History of pregnancy with fetal or neonatal growth and developmental defects; 8.History of or current use of nephrotoxic drugs, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators; 9.Ultrasound before medication indicates fetal malformations, abnormal fetal development, placental abnormalities, threatened miscarriage, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative HBV-DNA results during pregnancy;Quantitative HBeAg results during pregnancy;Quantitative HBsAg results during pregnancy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy complications;Birth defects, birth weight, height, head circumference, weight, height, head circumference at 7 months, hepatitis B serology;Liver Ultrasound During Pregnancy;ALT, AST, total bilirubin, direct bilirubin, creatinine, total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, albumin, and total bile acids from pregnancy to delivery;Fetal ultrasound results; | — |
Countries
China
Contacts
Public ContactXingfei Pan
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed